Medical headgear

ABSTRACT

A medical headgear fabric that includes, at least: (i) a skin-facing fabric layer; (ii) an outermost fabric layer; and (iii) a plastic or metal layer located between the fabric layers. Preferably these layers, as well as any additional layers that may be present in the fabric are thermoformed to form a substantially unitary fabric with at least a substantially laminate structure. Preferably, the fabric also includes a foam layer located between the fabric layers. Preferably, in embodiments with a layer (iii) of plastic, the plastic layer is in the form of a nylon, plastic strip. Preferably, in embodiments with a layer (iii) of metal, the metal layer is in the form of an aluminum strip.

The present application claims priority to the following U.S.provisional patent applications: Ser. No. 61/056,924 filed on May 29,2008, Ser. No. 61/056,917 filed on May 29, 2008, and Ser. No. 61/056,913filed on May 29, 2008, all of the foregoing patent-related document(s)are hereby incorporated by reference herein in their respectiveentirety(ies).

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to medical headgear fabrics and moreparticularly to a headgear for treatment of sleep apnea.

2. Description of the Related Art

Medical headgear for the treatment of respiratory conditions such assleep apnea vary depending upon the nature and severity of thecondition. In some conventional sleep apnea headgear designs, theheadgear is fabricated of material having an intermediate rigidity,somewhere between pliable and bendable, whereby this rigidity is not“rigid” as defined by the Definitions set forth hereinafter. FIG. 1shows an exploded view partial cross-section for one conventional sleepapnea headgear fabric 100, having three layers: (i) an outernylon-LYCRA® layer 102; (ii) a breathable foam layer 104; and (iii) askin-facing nylon-LYCRA® layer 106. The three layers 102, 104, 016 areflame laminated to form the three layer laminate shown (in explodedform) in FIG. 1.

Conventionally, headgear 100 is made by flame lamination. Flamelamination is a process used, typically in the textile industry, topermanently join fabrics and/or foam/neoprene to provide functionalityfor specific applications. More specifically, a polyurethane (PU) foamand two nylon/spandex blends form a three layer composite. The PU is fedinto one side of the flame lamination machine at the same one of thefabrics is also fed in. The top surface of the foam is melted by directflame contact to generate a tacky condition. The melted foam and fabricare then fed through a compression roller to squeeze the two materialstogether forcing the melted foam into the pores of the fabric. As itcools a bond is formed. This process is then repeated to bond the otherfabric to the foam.

Thermoforming is a conventional process used to make laminate products,such as shoe insoles, but it is not believed to be conventionally usedto make medical headgear fabrics and/or sleep apnea headgear fabrics.

U.S. Pat. No. 6,019,101 (“Cotner”) discloses a nasal mask for treatmentof sleep apnea. The Cotner mask includes a strap made from anelastically compliant material and a plastically deformable nose clip.The deformable nose clip may be manufactured from thin aluminum

U.S. Pat. No. 6,269,814 (“Blaszczykiewicz”) discloses a sleep apneaheadgear including a chinstrap made from a stretchable, breathable,laminated neoprene substitute. The inner surface of the chinstrap ismade from LYCRA® fabric. The outer surface of the chinstrap is made ofUBL loop material.

U.S. Pat. No. 6,470,886 (“Jestrabek-Hart”) discloses a headgear fortreating sleep apnea including two panels. Each panel includes thefollowing layers: (i) a skin-facing layer of soft, flexible cloth,pleasant to the touch; (ii) a plastic layer (ear encircling regiononly); (iii) soft flexible foam layer; and (iv) cloth outside surfacelayer. Although it is not immediately clear, it appears that the clothoutside surface layer, layer (iv), may be either covered, partiallycovered and/or replaced by a layer of material made of hook-and-loopfastener fabric (specifically, the hook side). As shown in FIG. 5 ofJestrabek-Hart, the Jestrabek-Hart headgear fabric has foam on only oneside of its plastic layer. This construction may allow the plastic layerto tear through the outer fabric. Also, this construction will have alow degree of softness on the side of the plastic layer that has nofoam.

U.S. Pat. No. 6,805,117 (“Ho”) discloses a headgear including mesh-likepanels(s) and a rear joint piece. The panels(s) are made from anylon-LYCRA® blend. The rear joint piece is made from LYCRA® laminatedfoam or neoprene.

U.S. Pat. No. 7,047,972 (“Ging”) discloses a respiratory mask includingyokes and straps. The straps are made of laminated fabric and foam. Gingdiscloses that one commercially available material is “Beath-O-Prene”™manufactured by Accumed, Inc. USA. The yokes are attached to the strapsand are made of somewhat rigid plastic, such as nylon or polypropylene.It is noted that the yokes of the Ging mask are attached to the outsideof the straps and not embedded within the laminate structure of thestrap itself It is believed that the Ging fabric requires separateattachment mechanisms such as sewing or clamping to secure its embeddedplastic. Also, Ging is directed to a mask, and not a headgear or a sleepapnea headgear.

U.S. patent application 2006/0081250 (“Bordewick”) discloses a nasalmask includes a mask holder and a stabilizing band. The mask holder ismade out of rigid or semi-rigid material, such as glass-filled nylon.

U.S. patent application 2007/0181135 (“Baker”) discloses a headgearassembly to treat sleep apnea. The Baker assembly includes a crown strapand a chin strap. The chin strap and crown straps are made of abreathable, elastic foam material laminated on both sides with a soft,moisture-wicking fabric. The outside fabric includes LYCRA® spandex andan anti-microbial agent, such as silver.

Description Of the Related Art Section Disclaimer: To the extent thatspecific publications are discussed above in this Description of theRelated Art Section, these discussions should not be taken as anadmission that the discussed publications (for example, publishedpatents) are prior art for patent law purposes. For example, some or allof the discussed publications may not be sufficiently early in time, maynot reflect subject matter developed early enough in time and/or may notbe sufficiently enabling so as to amount to prior art for patent lawpurposes. To the extent that specific publications are discussed abovein this Description of the Related Art Section, they are all herebyincorporated by reference into this document in their respectiveentirety(ies).

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention are directed to a medical headgearfabrics that include, at least: (i) a skin-facing fabric layer; (ii) anoutermost fabric layer; and (iii) a layer of rigid material such as a“rigid” (see DEFINITIONS section) plastic material located between thefabric layers. Preferably these layers, as well as any additional layersthat may be present in the fabric are thermoformed to form asubstantially unitary fabric with at least a substantially laminatestructure. Preferably, the fabric also includes a foam layer locatedbetween the fabric layers. Preferably, in embodiments with a layer (iii)of plastic, the plastic layer is in the form of a nylon, plastic strip.

Various embodiments of the present invention may exhibit one or more ofthe following objects, features and/or advantages:

-   -   (1) lamination by thermoforming to produce a thicker, more        comfortable shape in the headgear made with the headgear fabric        of the present invention;    -   (2) lamination by thermoforming to produce a headgear made with        the headgear fabric of the present invention that more naturally        conforms to the roundness of the human head;    -   (3) use of a metal layer in the headgear fabric to provide        clearance from the patient's face;    -   (4) use of a metal layer in the headgear fabric to provide        comfort to the patient's face;    -   (5) use of a rigid plastic layer to reduce or eliminate        bulkiness in the headgear;    -   (6) use of a rigid plastic layer and/or a metal layer to replace        external plastic parts for making connections to a breathing        mask portion of the headgear;    -   (7) use of a rigid plastic layer and/or a metal layer to replace        separate nylon rigidizers and/or yokes;    -   (8) use of a rigid plastic layer, preferably unitarily formed        with the fabric, to reduce complexity of the assembly;    -   (9) use of a rigid plastic layer, preferably unitarily formed        with the fabric, to reduce potential for the assembled fabric to        disassemble;    -   (10) use of a rigid plastic layer, preferably unitarily formed        with the fabric, to making a cleaner looking headgear with a        more appealing visual appearance;    -   (11) use of a rigid plastic layer to add straight-ahead        stiffness to the strap arm;    -   (12) use of a metal layer to enhance adjustability of the        headgear; and/or    -   (13) improved rigidity, especially in strap arm sections, helps        hold a sleep apnea headgear tightly enough against the face so        that the amount of pressurized air escaping along the skin is        reduced or eliminated.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be more fully understood and appreciated byreading the following Detailed Description in conjunction with theaccompanying drawings, in which:

FIG. 1 is a partial cross-sectional view of a prior art medical headgearfabric;

FIG. 2 is a partial cross-sectional view of a first embodiment of amedical headgear fabric according to the present invention;

FIG. 3 is a partial cross-sectional view of a second embodiment of amedical headgear fabric according to the present invention;

FIG. 4 is a partial cross-sectional view of a third embodiment of amedical headgear fabric according to the present invention;

FIG. 5 is a partial cross-sectional view of a second embodiment of asleep apnea headgear according to the present invention;

FIG. 6 shows a top orthographic view of a sleep apnea headgear overallgeometry corresponding to both first and second sleep apnea headgearembodiments according to the present invention;

FIG. 7 shows a perspective view of the first embodiment of the sleepapnea headgear as it is being manipulated by a person;

FIG. 8 shows a perspective view of the first embodiment of the sleepapnea headgear as it is being manipulated by a person;

FIG. 9 shows a top orthographic view of the second embodiment of thesleep apnea headgear;

FIG. 10 shows a perspective view of the second embodiment of the sleepapnea headgear as it is being manipulated by a person; and

FIG. 11 shows a perspective view of the second embodiment of the sleepapnea headgear as it is being manipulated by a person.

DETAILED DESCRIPTION OF THE INVENTION

-   -   I. Headgear Fabric Structures

As will be appreciated, embodiments of the present invention provideheadgear fabric and devices fabricated of materials that exhibit comfortand flexibility to the wearer, while concurrently providing stabilityand integrity to the headgear device.

Embodiments of the headgear are fabricated of a variety of layers ofmaterials. Depending on the section or part of the headgear, the layersmay or may not vary. Reference is made to FIG. 2 (not to scale), whichshows a medical headgear fabric 200 including: a skin-facing fabriclayer 206; a foam layer 208; a layer of rigid material 210; and an outerfabric layer 212. The skin-facing fabric layer includes skin-facingsurface 202 (reference numeral 201 designates the skin, scalp or otherportion of the patient that this fabric is intended to face or contact).The skin facing layer may be fabricated of any soft, fabric that iscomfortable to the skin. The fabric may also exhibit stretch,elasticity, and/or wicking properties. Examples include, but are notlimited to a nylon-LYCRA® blend, and microfiber knit fabric. The primarybenefit of this layer is provide minimal friction with the person'sskin. It is preferable that the knit fabric is porous and allows airflowto reduce perspiration. The skin-facing fabric may be treated with achemical that promotes wicking, i.e., transportation of moisture,through to the next layer of the assembly.

The foam layer 208 provides cushioning and is preferably breathable,aiding in allowing moisture to move away from the skin toward theoutside atmosphere by means of capillary attraction. The foam may befabricated of a cellular, stretch-elastomer foam such as that describedabove for section 104, including but not limited to polyurethane foam.

The layer of rigid material 210 is any rigid material that providesintegrity to the structure without the need for an external support orstructure (such as rigidizers or yokes that arc typically applied tosimilar structures on the external surface). The material may be anyplastic, composite, metal, or ceramic material having enough strength toprovide integrity to the structure, but also allows for someflexibility. Examples of materials include, but are not limited to,thermoplastic and fiber reinforced thermoplastic materials. Examples ofthermoplastic materials include, but are not limited to, polyamides.Examples of polyamides include, but are not limited to, nylon 6 andnylon 12.

The rigid material 210 may be smaller in dimensions (i.e., theperimeter) than the dimensions of the layers it is juxtaposed or thoselayers positioned over or under thereto, i.e, layers 206, 208, 212, suchthat it can be centered in the assembly so that its sharp edges do notextend past the edge of the assembled structure, causing irritation tothe person's skin. This rigid material provides a degree of stiffness tothe assembly, particularly to the strap arm sections of a headgeardevice, to provide proper and appropriate placement of the device on theperson's face and crown, as further described below in the HeadgearGeometry section

The outer fabric layer 212 includes outer surface 204 and may be amaterial similar to material used to fabricate layer 206 such as anylon-LYCRA® blend, or microfiber knit fabric. It may further include anattachment means such as a series of small loops that provide a vehiclefor engagement with a hook material to create the force that holds theheadgear in place on the person. Structure 200 is merely exemplary andmay include additional layers or layers disposed in a different orderthan shown in FIG. 2. For example, the order of layers 208 and 210 maybe reversed.

It is preferable that the layers are thermoformed or thermoset togetheras further described below, to provide a finished product having onlyone seam or edge that is located away from the skin, on the outer fabriclayer 212, to reduce any opportunity for skin irritation. Althoughthermoforming is preferable, the embodiments herein are not limited tothis fabrication process and some variations may include some or all ofthe adjacent layers not being laminated to each other at all. Also, inembodiments where all of the adjacent layers are laminated together toform a unitary structure, other lamination processes may be used such asflame lamination.

Fabric 200 has good straight-ahead stiffness which means that theplastic layer helps direct certain sections of the headgear (forexample, strap arm sections) in a specific direction, which can helpfacilitate assembly of medical headgears using fabric 200 to a facemask, such as a sleep apnea headgear face mask. This can obviate theneed for a large of amount of different-sized headgear in order toaccommodate a larger range of patient head sizes. Although not limitedto any particular section o f the headgear, it is preferable that alayered structure such as fabric 200 be used in the strap arm sectionsof the headgear, discussed further below under the Headgear Geometrysection.

FIG. 3 (not to scale) shows a medical headgear fabric 300 including: askin-facing fabric layer 306; a foam layer 308; a metal layer 310; andan outer fabric layer 312. The skin-facing fabric layer 306 includesskin-facing surface 302 (reference numeral 301 designates the skin,scalp or other portion of the patient that this fabric is intended toface or contact) and can be fabricated of any soft fabric as indicatedabove for layer 206. The foam layer 308 is preferably breathable and maybe fabricated of the same material discussed above in connection withlayer 208. The metal layer 310 is preferably made of aluminum, and evenmore preferably made of galvanized aluminum. The outer fabric layer 312includes outer surface 304 and is preferably made of similar materialsas used to fabricate layer 212 above. As stated above for fabric orstructure 200, the order of layers in fabric or structure 300 may alsobe reversed, such as layers 308 and 310. Also additional layers may bepresent.

As with structure or fabric 200, it is preferable that the layers ofstructure or fabric 300 are thermoformed or thermoset together asfurther described below, to provide a finished product having only oneseam or edge that is located away from the skin, on the outer fabriclayer 312 or on surface 304, to reduce any opportunity for skinirritation. Although thermoforming is preferable, the embodiments hereinare not limited to this fabrication process and some variations mayinclude some or all of the adjacent layers not being laminated to eachother at all. Also, in embodiments where all of the adjacent layers arelaminated together to form a unitary structure, other laminationprocesses may be used such as flame lamination.

Fabric 300 has good moldability. The metal layer helps: (i) fewer sizesof headgears accommodate a larger range of patient head sizes; and (ii)create clearances for comfort and spacing.

FIG. 4 (not to scale) shows a medical headgear fabric 350 including: askin-facing fabric layer 356; a foam layer 358; a metal layer 360; arigid plastic layer 362 and an outer fabric layer 364. The skin-facingfabric layer includes skin-facing surface 352 (reference numeral 351designates the skin, scalp or other portion of the patient that thisfabric is intended to face or contact). The materials used for layers356, 358, 360, 362 and 364 may be the same as or similar to thosematerials used in the fabrication of fabrics 200 and 300, where likesections can use the same or similar fabric, as discussed above.

FIG. 5 shows a partial cross section of a headgear 500 including a crownsection 524 and a strap section 526. Crown section 524 includes: a firstcrown section layer 502; a second crown section layer 504; a third crownsection layer 506; and a fourth crown section layer 508. Joint 510connects crown section 524 to strap section 526. Strap section 526includes a first strap arm section layer 512; a second strap arm sectionlayer 514; a third strap arm section layer 516; a fourth strap armsection layer 518; a fifth strap arm section layer 520; and a fastenerlayer 522. FIG. 5 also shows where the layers are located with respectto the headgear sections 524, 526, 528 shown in FIG. 6.

First crown section and fourth crown section layers 502 and 508,respectively, are preferably made of soft, stretchy fabric, the same asor similar to those materials discussed above or fabrics/structures 200,300 and 400. Alternatively, some or all of the fourth crown sectionlayer 508 may be made of fastener material, such as hook and loopfastener material, in order to facilitate attachment of other componentsto the headgear, such as a sleep apnea face mask (not shown). Secondcrown section layer 504 is preferably made of relatively high densityfoam, such as 10 lb density foam. Third crown section layer 506 ispreferably made of relatively low density foam, such as 7 lb densityfoam.

First strap arm section and fifth strap arm section layers 512 and 520,respectively, are preferably made of soft, stretchy fabric.Alternatively, some or all of the fifth crown section layer may be madeof fastener material, such as hook and loop fastener material, in orderto facilitate attachment of other components to the headgear, such as asleep apnea face mask (not shown). Under this alternative, fastenersection 528 with fastener layer 522 may no longer be needed because thefastener fabric would already be present as the fifth layer. Second andfourth strap arm section layers 514, 518, respectively, are preferablymade of relatively low density foam, such as 7 lb density foam. Thirdstrap arm section layer 516 is a rigid material such as a rigid plasticlayer, as discussed above in connection with fabric 200. Alternatively,or additionally, this layer 516 could be a metal, ceramic or compositelayer as discussed above in connection with fabric 300.

The thickness, strength and hardness of each of the layers discussedabove, may vary depending on the size and strength needed for theparticular headgear device.

-   -   II. Overall Headgear Geometry

The medical headgear fabrics discussed above may be used in a widevariety of geometrically shaped headgear designs. In some preferredembodiments of the present invention, different fabrics, with differentlaminate structures, are used for different sections of the headgear.

FIG. 6 shows a top orthographic view of a sleep apnea headgear overallgeometry common to a first embodiment 500 and a second embodiment 600 oftwo exemplary sleep apnea headgears according to the present invention.As shown in FIG. 6, headgear 500 includes: a crown section 524; fourstrap arm sections 526 a,526 b,526 c,526 d; and a fastener section 528.As shown in FIG. 6, headgear 600 includes: a crown section 624; and fourstrap arm sections 626 a,626 b,626 c,626 d.

The main difference between headgear 500 and headgear 600 is thatheadgear 500 uses fabric 300 in its strap arm sections, while headgear600 uses fabric 200 in its strap arm sections. Although this overallgeometry 500, 600 is preferred, the use of the medical device headgearfabrics according to the present invention is not necessarily limited towhat is shown in FIG. 6. This headgear geometry design, including straparms and a crown section, is sometimes be referred to as a 3D headgearbecause it has multiple sections, with different sections havingdifferent thicknesses.

FIGS. 7 and 8 show the versatility facilitated by the use of a metallayer in the headgear fabric 300 to provide clearance from and/orcomfort to a patient's face.

FIGS. 9 to 11 show how a headgear 600 made of fabric 200 and including arigid plastic layer can be shaped and manipulated to help bring aboutthe advantages described herein.

-   -   III. Fabric Forming Processes

Flame lamination can be used to make medical headgear fabrics accordingto the present invention, but it is not the preferred process. Thepreferred thermoforming process utilizes a polyurethane (PU) foam andtwo nylon/spandex blends to form a three layer composite. The PU is fedinto one side of the lamination machine at the same one of the fabricsis also fed in. The top surface of the foam is melted by direct flamecontact to generate a tacky condition. The melted foam and fabric isthen fed through a compression roller to squeeze the two materialstogether forcing the melted foam into the pores of the fabric. As itcools a bond is formed. This process is then repeated to bond the otherfabric. Thermoforming takes previously laminated composites and utilizesa combination of heat (not flame) and pressure to generate permanentshapes and variable height within the composite.

For multi-layered products like the medical headgears of the presentinvention, the final composite is typically generated by taking twoseparate two-layer laminate sub-assemblies, inserting the plasticbetween these sub-assemblies, spraying some adhesive between theselayers and then thermoforming the sub-assemblies together. The heat andpressure from the thermoforming process then causes the reaction in theadhesive that parts bonds the subassemblies and inserts together.Thermoforming provides more thickness and softness to the headgear forincreased patient comfort. The thermoforming process can be used to makemedical headgear fabrics with a plastic layer, such as fabric 200, orfabrics with a metal layer, such as fabric 300.

The fabric and headgear described herein provide all-textile, completelysoft and drapable devices that provide comfort and flexibility to thewearer while maintaining stability and control on the wearer's head. Theintegrity of the fabric and device is provided internally, notexternally to add to the comfort of the device. There are no stitches orseams present on the skin-surface side of the fabric. Accordingly, skinirritation is reduced and/or alleviated by the fabric and devicedescribed herein.

DEFINITIONS

The following definitions are provided to facilitate claiminterpretation and claim construction:

Present invention: means at least some embodiments of the presentinvention;

references to various feature(s) of the “present invention” throughoutthis document do not mean that all claimed embodiments or methodsinclude the referenced feature(s).

First, second, third, etc. (“ordinals”): Unless otherwise noted,ordinals only serve to distinguish or identify (e.g., various members ofa group); the mere use of ordinals implies neither a consecutivenumerical limit nor a serial limitation.

Rigid plastic: any plastic layer at least substantially more rigid thanfoam.

To the extent that the definitions provided above are consistent withordinary, plain, and accustomed meanings (as generally shown bydocuments such as dictionaries and/or technical lexicons), the abovedefinitions shall be considered supplemental in nature. To the extentthat the definitions provided above are inconsistent with ordinary,plain, and accustomed meanings (as generally shown by documents such asdictionaries and/or technical lexicons), the above definitions shallcontrol. If the definitions provided above are broader than theordinary, plain, and accustomed meanings in some aspect, then the abovedefinitions shall be considered to broaden the claim accordingly.

To the extent that a patentee may act as its own lexicographer underapplicable law, it is hereby further directed that all words appearingin the claims section, except for the above-defined words, shall take ontheir ordinary, plain, and accustomed meanings (as generally shown bydocuments such as dictionaries and/or technical lexicons), and shall notbe considered to be specially defined in this specification. In thesituation where a word or term used in the claims has more than onealternative ordinary, plain and accustomed meaning, the broadestdefinition that is consistent with technological feasibility and notdirectly inconsistent with the specification shall control.

Unless otherwise explicitly provided in the claim language, steps inmethod steps or process claims need only be performed in the same timeorder as the order the steps are recited in the claim only to the extentthat impossibility or extreme feasibility problems dictate that therecited step order (or portion of the recited step order) be used. Thisbroad interpretation with respect to step order is to be used regardlessof whether the alternative time ordering(s) of the claimed steps isparticularly mentioned or discussed in this document.

1-25. (canceled)
 26. A headgear to support a sleep apnea face mask on apatient, comprising: a thermoformed crown section configured to extendover a portion of the patient's head, the thermoformed crown sectionincluding: a first skin-facing fabric layer configured to contact thepatient's skin; a first outer fabric layer; and at least one first foamlayer located between the first skin-facing fabric layer and the firstouter fabric layer, wherein the first skin-facing fabric layer, thefirst outer fabric layer and the at least one first foam layer arethermoformed together; and at least one thermoformed strap sectionconnected to the crown section, each thermoformed strap sectionincluding: a second skin-facing fabric layer configured to contact theuser's skin; a second outer fabric layer; and at least one second foamlayer located between the second skin-facing fabric layer and the secondouter fabric layer, wherein the second skin-facing fabric layer, thesecond outer fabric layer and the at least one second foam layer arethermoformed together, and wherein the at least one thermoformed strapsection is configured to be attached to a sleep apnea face mask tosupport the face mask on the patient's face.
 27. The headgear of claim26, wherein the thermoformed crown section forms a crown unitarylaminate structure and the at least one thermoformed strap section formsa strap unitary laminate structure.
 28. The headgear of claim 26,wherein the at least one first foam layer comprises two layers of foam.29. The headgear of claim 26, wherein the at least second foam layercomprises two layers of foam.
 30. The headgear of claim 26, wherein theat least one thermoformed strap section includes four thermoformed strapsections.
 31. The headgear of claim 26, wherein a fastener layer isattached to an outer surface of the second outer fabric layer of eachthermoformed strap section.
 32. The headgear of claim 31, wherein an endportion of each thermoformed strap section includes hooks for engagementwith loops to attach the face mask to the headgear.
 33. The headgear ofclaim 32, wherein the loops are provided by the second outer fabriclayer of each thermoformed strap section.
 34. The headgear of claim 26,wherein at least a portion of the headgear has a variable height due tothermoforming.
 35. The headgear of claim 26, wherein at least one of thefirst skin-facing fabric layer and the first outer fabric layer islaminated onto the at least one first foam layer.
 36. The headgear ofclaim 26, wherein each of the first skin-facing fabric layer and thesecond skin-facing fabric layer comprises a soft, stretchable fabric.37. The headgear of claim 26, wherein each of the first outer fabriclayer and the second outer fabric layer comprises a soft, stretchablefabric.
 38. The headgear of claim 26, further comprising a joint toconnect the at least one thermoformed strap section to the thermoformedcrown section.
 39. The headgear of claim 26, further comprising a jointto connect the at least one thermoformed strap section to thethermoformed crown section, wherein the thermoformed crown section formsa crown unitary laminate structure, wherein the at least onethermoformed strap section forms a strap unitary laminate structure,wherein the at least second foam layer comprises two layers of foam,wherein a fastener layer is attached to an outer surface of the secondouter fabric layer of each thermoformed strap section, wherein an endportion of each thermoformed strap section includes hooks for engagementwith loops to attach the face mask to the headgear, and wherein theloops are provided by the second outer fabric layer of each thermoformedstrap section.
 40. A headgear to support a sleep apnea face mask on apatient, comprising: a thermoformed crown section configured to extendover a portion of the patient's head, the thermoformed crown sectionincluding: a first skin-facing fabric layer configured to contact thepatient's skin; a first outer fabric layer; and at least one first foamlayer located between the first skin-facing fabric layer and the firstouter fabric layer, wherein the first skin-facing fabric layer, thefirst outer fabric layer and the at least one first foam layer arethermoformed together thereby forming a crown unitary laminatestructure; and at least one thermoformed strap section connected to thecrown section, the at least one thermoformed strap section includingfirst and second thermoformed strap sections, wherein a first portion ofthe thermoformed crown section proximal the first thermoformed strapsection has a width that is different from a width of a second portionof the thermoformed crown section distal to the first thermoformed strapsection.
 41. The headgear of claim 40, wherein each thermoformed strapsection includes: a second skin-facing fabric layer configured tocontact the user's skin; a second outer fabric layer; and at least onesecond foam layer located between the second skin-facing fabric layerand the second outer fabric layer, wherein the second skin-facing fabriclayer, the second outer fabric layer and the at least one second foamlayer are thermoformed together, and wherein the at least onethermoformed strap section is configured to be attached to a sleep apneaface mask to support the face mask on the patient's face.
 42. Theheadgear of claim 41, wherein the at least second foam layer comprisestwo layers of foam.
 43. The headgear of claim 41, wherein each of thefirst skin-facing fabric layer and the second skin-facing fabric layercomprises a soft, stretchable fabric.
 44. The headgear of claim 41,wherein each of the first outer fabric layer and the second outer fabriclayer comprises a soft, stretchable fabric.
 45. The headgear of claim40, wherein the at least one first foam layer comprising two layers offoam.
 46. The headgear of claim 40, wherein the at least onethermoformed strap section forms a strap unitary laminate structure. 47.The headgear of claim 40, wherein the at least one thermoformed strapsection includes four thermoformed strap sections.
 48. The headgear ofclaim 40, wherein a fastener layer is attached to an outer surface ofthe second outer fabric layer of each thermoformed strap section. 49.The headgear of claim 48, wherein an end portion of each thermoformedstrap section includes hooks for engagement with loops to attach theface mask to the headgear.
 50. The headgear of claim 49, wherein theloops are provided by the second outer fabric layer of each thermoformedstrap section.
 51. The headgear of claim 40, wherein at least a portionof the headgear has a variable height due to thermoforming.
 52. Theheadgear of claim 40, wherein at least one of the first skin-facingfabric layer and the first outer fabric layer is laminated onto the atleast one first foam layer.
 53. The headgear of claim 40, furthercomprising a joint to connect the at least one thermoformed strapsection to the thermoformed crown section.
 54. The headgear of claim 40,wherein the width of the first portion of the thermoformed crown sectionis less than the width of the second portion of the thermoformed crownsection.
 55. The headgear of claim 40, further comprising a joint toconnect the at least one thermoformed strap section to the thermoformedcrown section, wherein each thermoformed strap section includes: asecond skin-facing fabric layer configured to contact the user's skin; asecond outer fabric layer; and at least one second foam layer locatedbetween the second skin-facing fabric layer and the second outer fabriclayer, wherein the second skin-facing fabric layer, the second outerfabric layer and the at least one second foam layer are thermoformedtogether, and wherein the at least one thermoformed strap section isconfigured to be attached to a sleep apnea face mask to support the facemask on the patient's face, wherein a fastener layer is attached to anouter surface of the second outer fabric layer of each thermoformedstrap section, wherein an end portion of each thermoformed strap sectionincludes hooks for engagement with loops to attach the face mask to theheadgear, and wherein the loops are provided by the second outer fabriclayer of each thermoformed strap section.